Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource (B-SCR-MM)

Verified April 2017 by Craig Hofmeister, Ohio State University Comprehensive Cancer Center

Sponsor:

Ohio State University Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT01408225

First Posted: August 3, 2011

Last Update Posted: April 5, 2017

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The investigators are researching patients with diseases of their plasma cells in order to improve their quality and length of life. The investigators have created a database of patient information, blood samples, and bone marrow tissue in order to achieve the following three goals:

Surveillance: The investigators want to track what treatments patients get or don't get, how effective they are, how they feel, what complications they suffer, how long they stay in remission, and how long they live.

Contact: Because myeloma and amyloidosis are rare, less than 700 patients are diagnosed in the state of Ohio each year, patients often feel they don't have accurate information. The investigators want to provide them access to our clinical team (both phone and email consultations, even office visits for patients that can come to Columbus) as well as information regarding informational events pertaining to your disease and local support groups.

Research: Because nearly all myeloma and amyloid patients relapse and treatment is eventually unsuccessful, our focus is to develop more effective treatments that not only prolong life, but cure the disease. Periodically the investigators will inform them about clinical trials studying new drugs or treatment paradigms.

Further study details as provided by Craig Hofmeister, Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:

Develop a data and sample resource that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality of patients diagnosed or living with Multiple Myeloma in the state of Ohio [ Time Frame: up to 3 years ]

Secondary Outcome Measures:

Surveillance [ Time Frame: up to 3 years ]

Establish a database of myeloma patients diagnosed or living in the state of Ohio to track myeloma disease course, patient reported outcomes, morbidity, and patient survival.

Contact [ Time Frame: up to 3 years ]

Provide two-way communication with patients by providing information regarding multiple myeloma, local support groups, and standard of care procedures through active contact procedures

Research [ Time Frame: up to 3 years ]

Offer patients, and occasionally spouses and family members, the opportunity to participate in tissue banking, observational, patient reported outcomes, and therapeutic clinical trials for their plasma cell dyscrasia.

Estimated Enrollment:

5000

Study Start Date:

March 2011

Estimated Primary Completion Date:

March 2021 (Final data collection date for primary outcome measure)

Intervention Details:

Procedure: tissue banking

tissue procurement for this protocol will occur at the time of initial diagnosis, during routine follow-up, or at the time of relapse.

Detailed Description:

The investigators propose to contact and interact with all patients with plasma cell dyscrasias in the State of Ohio (and all patients diagnosed or treated at Ohio State Medical Center) for both surveillance and research purposes in order to develop interventions targeted to decrease their morbidity and mortality.

Eligibility

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Patients treated or diagnosed within the state of Ohio

Criteria

Inclusion:

Diagnosis of a plasma cell dyscrasia

Exclusion:

Prisoners are excluded from participation as they have no standard access to the Ohio State myeloma clinic and would impede the research objective of this protocol.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408225